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Completed

NCT Number: NCT04644523

Dermoscopy in Primary Raynaud's Phenomenon

Raynaud's phenomenon (RP) is very frequent in general population (up to 10%). Nailfold capillaroscopy (NFC) is recommended for patients presenting RP, to eliminate systemic disease such as systemic sclerosis. NFC is not easily available in clinical practice. Dermoscopy, used for pigmentary skin lesion screening, may help to detect giant loops, hemorrhages or other capillaries anomalies. However, no study has evaluated the performance of dermoscopy in primary RP. The objective is to determinate which items in dermoscopy are correlated with a normal NFC and predict with a good negative predictive value, a normal NFC in RP patients. The secondary objective is to assess inter-observer reproducibility of dermoscopy in patients with RP.

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Key information

Conditions

Raynaud Phenomenon Cardiovascular Diseases Embolism and Thrombosis Livedoid Vasculopathy Peripheral Vascular Diseases Raynaud Disease Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Thrombosis Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital de Tenon

Paris, 75020, France

About this study

Raynaud's phenomenon (RP) is very frequent in general population (up to 10%). Nailfold capillaroscopy (NFC) is recommended for patients presenting RP, to eliminate systemic disease such as systemic sclerosis. NFC is not easily available in clinical practice. Dermoscopy, used for pigmentary skin lesion screening, may help to detect giant loops, hemorrhages or other capillaries anomalies. However, no study evaluated the performance of dermoscopy in primary RP. A preliminary study (Tenon Hospital) showed an interest of dermoscopy in primary and secondary RP, with a negative predictive value of dermoscopy of 100% for capillaroscopy.

This is a prospective, multicentric French study comparing dermoscopy and capillaroscopy in patients attending dermatology or vascular medicine departments for the first evaluation of a RP.

The objective is to determinate which items in dermoscopy are correlated with a normal NFC and predict with a good negative predictive value, a normal NFC in RP patients. The secondary objective is to assess inter-observer reproducibility of dermoscopy in patients with RP.

The main hypothesis is that a normal dermocopy on five items is highly predictive of a normal NFC.

During a first consultation for RP, NFC will be realized with a clinical exam and a biological test (antinuclear antibodies), as official recommendations. Dermoscopy of peri-ungueal area will be realized by another investigator, if possible during the same consultation. Photographs of all fingers, except thumbs, will be made and will be reviewed by another investigator of another center. There will be no follow-up.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18 years
  • first consultation for bilateral Raynaud's phenomenon (RP)
  • Bilateral Raynaud's phenomenon affecting at least one finger of each hand defined by a paroxysmal syncopal phase on exposure to cold,
  • Affiliated to the French health care systeme

Exclusion criteria

  • age < 18 years
  • Presence of unilateral RP where the capillaroscopy is normal regardless of the cause

Treatment and study plan

Dermoscopy

Other

dermoscopy is currently used in daily practice in dermatology, for melanoma screening. Dermoscopy will be used in this study on peri-ungueal area.

This is a non-invasive and painless exam.

Primary outcomes

  1. Dermoscopic items

    Time frame: November 2022

    To determine wich dermoscopic items predict normal capillaroscopy in a first-time attending RP.

Secondary outcomes

  1. Photography

    Time frame: November 2022

    Reproducibility of dermoscopy for the 5 items: all photographs of dermoscopy will be reviewed by another investigator from another center.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Prospective Validation of 5 Items in Nailfold Dermoscopy to Predict a Normal Capillaroscopy in Raynaud's Phenomenon

Acronym: VASCUL-R

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 25, 2020
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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